Evidence Delivery Associate Director

3 weeks ago

Mississauga, Canada AstraZeneca Full time

**Business Area**:
BioPharmaceuticals Medical (**BPM**) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AZ therapies and support our internal stakeholders with medical insight and expertise. BPM provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. BPM aims to lead AstraZeneca in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.

**About the role**:
Evidence Delivery Associate Directors (**EDAD**) will lead or support the operational planning, delivery, oversight and budget management of company and/or externally sponsored research. They may also help coordinate the efforts of extended team members, notably the scientific study leader (epidemiologist for observational studies, Medical Affairs Leader for interventional studies). The EDAD may own specific areas or deliverables within a study, or in some cases, assume the accountabilities of a team leader for study delivery.

In addition, the EDAD will support BPM Evidence’s continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and

maintenance of guidance documents and training materials.

Usually, the EDAD’s focus will be on one of the three main types of work as described below.

**Roles & Responsibilities**:
**Company Sponsored Observational and Interventional Research**:

- Company sponsored observational and interventional research
- Support/coordinate protocol development and finalization
- Manage Study Governance (post SDC)
- Support/coordinate all internal, study governance processes (e.g. ERT, MARC, LSPC, Clinical Challenge)
- External Service Provider Management
- Provide input into the selection of External Service Providers (ESPs), including Clinical Research Organisations (CROs)
- Support strategic handover meetings and kick off meetings
- Perform CRO oversight to help ensure project delivery within time, cost and quality
- Collaborate with CRO/ESP to ensure the study operational aspects are effectively undertaken and that they have clear remits for delivery
- Manage study specific issues and escalations with ESPs/CROs
- Stakeholder Management
- Support Project team set-up and study sourcing activities
- Support effective collaboration with the scientific/medical counterpart, the Epidemiologist/Global Medical Affairs Leader (GMAL) respectively, as well as other internal cross functional global roles
- Report study updates for areas of responsibility from a time, cost and quality perspective to internal stakeholders (e.g. Evidence Delivery Director(EDD))
- Support implementation and upkeep of an effective communication approach, as well as roles and responsibilities between the BPM Evidence stakeholders, local AZ and External Service Providers
- Coordinate efforts/input of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during project design and delivery

**Manage study finance**:

- If leading a study, develop and maintain the overall study budget (internal and external study costs)
- Ensure transparency over areas of budget responsibility by updating through relevant systems (s.a. ACCORD) and platforms (PPC meetings) and obtaining approval for budget changes
- Work with procurement on project agreement and manage subsequent out of scope changes for ESP/CRO
- Manage and reconcile Contracts, POs and invoices
- Support financial audit readiness and Sox attestation as needed

**Other **P**roject Management activities** **as applicable**
- Support delivery of projects to agreed timelines (scorecard), within the approved budget and according to AstraZeneca quality standards
- Support global oversight over the operational study start up, implementation and closure and ensure inspection-readiness
- Support implementation of study-related change management within business strategy, s.a. assessment of scope changes
- Ensure Compliance with AZ Procedural Documents, Standards and Policies, international guidelines and local regulations at any time, and report compliance breaches
- Undertake feasibility assessments with internal and external stakeholders
- Manage study systems reporting

**External**ly** Sponsored Scientific Research (ESR)**:
Manage across a range of global and local cross-functional stakeholders to ensure all AZ obligations and responsibilities for ESR (e.g. drug supply, contracting, regulatory documentation, publication review etc.) are met
- Manage external stakeholder, e.g. external Investigator and Sponsoring institutions
- Support ESR portfolio financial forecasting and budgeting for assigned ESR studies/portfolios, utilising appropriate Company systems to facilitate awareness and understanding of ESR budg

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